A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-04-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Age-related macular degeneration (AMD) is the leading cause of blindness among adults in North America. The current standard of care for patients with exudative ("wet") AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of patients with exudative AMD, and could offer an alternative, safer and less burdensome therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

NCT00088192

Macular Degeneration

COMPLETED NA

Pharmacogenomic Study on Anti-VEGF Medicine in Treatment of Macular Neovascular Diseases

NCT03128463

UNKNOWN

A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration

NCT00569140

Age-related Macular Degeneration

COMPLETED PHASE1

Phase II/III Study of Anti-VEGF in Neovascular AMD

NCT00021736

Macular Degeneration Choroidal Neovascularization

COMPLETED PHASE2/PHASE3

A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

NCT01089517

Age-Related Macular Degeneration

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MT-0814 High dose

Group Type EXPERIMENTAL

MT-0814

Intervention Type DRUG

Randomly assigned dose

MT-0814 Low dose

MT-0814 plus placebo

Group Type EXPERIMENTAL

MT-0814

Intervention Type DRUG

Placebo manufactured to mimic MT-0814

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must agree to sign informed consent form, and to comply with protocol requirements, including study visits.
* Must have clear optic media in the study eye that is capable of producing high-quality fundus images.

Exclusion Criteria

* Has active CNV due to causes other than AMD in the study eye.
* Has retinal vascular disease or retinal degeneration other than AMD in the study eye.
* Has had intraocular surgery, cataract surgery or LASIK surgery on the study eye within 90 days prior to the study.
* Has had yttrium aluminum garnet (YAG) laser capsulotomy on the study eye within 30 days prior to the study.
* Has active inflammation, infection, or other severe ocular disease in either eye.
* Has aphakia in the study eye.
* Has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either eye.
* Is a contact lens wearer and is unable to discontinue their use in both eyes for the duration of the study.
* Has a serious allergy to, or experienced a prior significant adverse reaction to fluorescein angiography (FA) or indocyanine green angiography (ICGA).
* Has participated in any other clinical trial and/or has taken any investigational drug or product within 90 days prior to the study.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No